Weaning FailureNCT01312142
Changes of Weaning Parameter in Weaning Failure Patient After Tracheostomy as a Predictor of Subsequent Weaning
An observational study of Weaning Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Weaning from mechanical ventilator is an essential element in the care of critically ill intubated patients receiving mechanical ventilation. It covers the entire process of liberating the patient from mechanical support and from endotracheal tube. The process of weaning involves two-step strategies: 1. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Weaning Failure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with difficult weaning and received subsequent tracheostomy
Who may be able to join
- All patients with prolonged mechanical ventilator support or difficult weaning who received tracheostomy subsequently.
Who cannot join
- Parturient
- Patient with upper airway obstruction
- Patients aged < 18 year old
- Patients who join other on going study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
About this study
Weaning from mechanical ventilator is an essential element in the care of critically ill intubated patients receiving mechanical ventilation. It covers the entire process of liberating the patient from mechanical support and from endotracheal tube.
The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning, including physiological measurement, such as maximum inspiratory pressure, tidal volume, respiratory rate and etc. 2. Spontaneous breathing trial.
Read more
Tracheostomy has become an increasingly common intervention in ICUs, especially for patients with prolonged mechanical ventilator support.
Tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics, such as reducing dead space and decreasing airway resistance, but to date, there is no evidence that this is linked to reduction in weaning time or length of stay.
The investigators believe such improvement in pulmonary mechanic, which may reflect in the weaning parameter that respiratory therapist measured before weaning program, may be different from that measured before tracheostomy creation.
The investigators therefore hypothesized that the improvement in pulmonary mechanic for patients with weaning failure after tracheostomy may reflect on weaning parameters, and that this improvement may be able to predict the subsequent successful weaning from mechanical ventilator support.
Hereby the investigators perform a prospective single-center study to investigate the changes of weaning parameters in difficult weaning patients after tracheostomy as a predictor of subsequent successful weaning.
Read the detailed description
Weaning from mechanical ventilator is an essential element in the care of critically ill intubated patients receiving mechanical ventilation. It covers the entire process of liberating the patient from mechanical support and from endotracheal tube1. The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning, including physiological measurement, such as maximum inspiratory pressure, tidal volume, respiratory rate and etc. 2. Spontaneous breathing trial. The incidence of successful weaning is estimated around 68.8%.
Despite there is no consensus on the optimal timing of tracheostomy, patients with prolonged trans-laryngeal intubation are finally succumbed to tracheostomy, as prolonged trans-laryngeal intubation causes tissue trauma, promotes bacterial translocation and infection, making tracheostomy an increasingly common intervention in ICUs. Meanwhile, tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics, such as reducing dead space and decreasing airway resistance, but to date, there is no evidence that this is linked to reduction in weaning time or length of stay.
Ｗe believe such improvement in pulmonary mechanics, which may reflect in the weaning parameters that respiratory therapist measured before weaning program, may be different after tracheostomy creation, especially in those patient with weaning failure. Ｗe therefore hypothesized that there may be an improvement in pulmonary mechanic for patients with weaning failure after tracheostomy, and that this improvement may be able to predict the subsequent successful weaning from mechanical ventilator support. Hereby the investigators perform a prospective single-center study to investigate the changes of weaning parameters in weaning failure patients after tracheostomy as a predictor of successful weaning.
- Conditions
- Weaning Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with difficult weaning | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of weaning parameters after tracheostomy
Weaning parameters are measured before and after tracheostomy creation too see if there is any changes
Measured: 5 days
Secondary outcomes (1)
To evaluate if changes in weaning parameters will predict successful weaning
We will first measure the changes of weaning parameters after tracheostomy. If changes do occur, we would like to evaluate if it will predict subsequent weaning feasibility.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jih-Shuin Jerng, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312142
- Sponsor's protocol ID
- 201012007RC
- Status last verified
- Dec 2011
- First submitted
- 8 Mar 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim CK, Ruan SY, Lin FC, Wu CL, Chang HT, Jerng JS, Wu HD, Yu CJ. Effect of Tracheostomy on Weaning Parameters in Difficult-to-Wean Mechanically Ventilated Patients: A Prospective Observational Study. PLoS One. 2015 Sep 17;10(9):e0138294. doi: 10.1371/journal.pone.0138294. eCollection 2015.
PubMed 26379127
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Weaning Parameter in Weaning Failure Patient After Tracheostomy as a Predictor of Subsequent Weaning
- ClinicalTrials.gov ID
- NCT01312142
- Acronym / sponsor ID
- 201012007RC
- Conditions
- Weaning Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Weaning from mechanical ventilator is an essential element in the care of critically ill intubated patients receiving mechanical ventilation. It covers the entire process of liberating the patient from mechanical support and from endotracheal tube.
The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning, including physiological measurement, such as maximum inspiratory pressure, tidal volume, respiratory rate and etc. 2. Spontaneous breathing trial.
Tracheostomy has become an increasingly common intervention in ICUs, especially for patients with prolonged mechanical ventilator support.
Tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics, such as reducing dead space and decreasing airway resistance, but to date, there is no evidence that this is linked to reduction in weaning time or length of stay.
The investigators believe such improvement in pulmonary mechanic, which may reflect in the weaning parameter that respiratory therapist measured before weaning program, may be different from that measured before tracheostomy creation.
The investigators therefore hypothesized that the improvement in pulmonary mechanic for patients with weaning failure after tracheostomy may reflect on weaning parameters, and that this improvement may be able to predict the subsequent successful weaning from mechanical ventilator support.
Hereby the investigators perform a prospective single-center study to investigate the changes of weaning parameters in difficult weaning patients after tracheostomy as a predictor of subsequent successful weaning.
Detailed description
Weaning from mechanical ventilator is an essential element in the care of critically ill intubated patients receiving mechanical ventilation. It covers the entire process of liberating the patient from mechanical support and from endotracheal tube1. The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning, including physiological measurement, such as maximum inspiratory pressure, tidal volume, respiratory rate and etc. 2. Spontaneous breathing trial. The incidence of successful weaning is estimated around 68.8%.
Despite there is no consensus on the optimal timing of tracheostomy, patients with prolonged trans-laryngeal intubation are finally succumbed to tracheostomy, as prolonged trans-laryngeal intubation causes tissue trauma, promotes bacterial translocation and infection, making tracheostomy an increasingly common intervention in ICUs. Meanwhile, tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics, such as reducing dead space and decreasing airway resistance, but to date, there is no evidence that this is linked to reduction in weaning time or length of stay.
Ｗe believe such improvement in pulmonary mechanics, which may reflect in the weaning parameters that respiratory therapist measured before weaning program, may be different after tracheostomy creation, especially in those patient with weaning failure. Ｗe therefore hypothesized that there may be an improvement in pulmonary mechanic for patients with weaning failure after tracheostomy, and that this improvement may be able to predict the subsequent successful weaning from mechanical ventilator support. Hereby the investigators perform a prospective single-center study to investigate the changes of weaning parameters in weaning failure patients after tracheostomy as a predictor of successful weaning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with difficult weaning | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with difficult weaning and received subsequent tracheostomy
Key inclusion criteria (1 listed)
- All patients with prolonged mechanical ventilator support or difficult weaning who received tracheostomy subsequently.
Key exclusion criteria (4 listed)
- Parturient
- Patient with upper airway obstruction
- Patients aged < 18 year old
- Patients who join other on going study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of weaning parameters after tracheostomy
Time frame: 5 days
Weaning parameters are measured before and after tracheostomy creation too see if there is any changes
1 secondary outcome
To evaluate if changes in weaning parameters will predict successful weaning
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
- Derived from this study: PubMed 26379127Lim CK, Ruan SY, Lin FC, Wu CL, Chang HT, Jerng JS, Wu HD, Yu CJ. Effect of Tracheostomy on Weaning Parameters in Difficult-to-Wean Mechanically Ventilated Patients: A Prospective Observational Study. PLoS One. 2015 Sep 17;10(9):e0138294. doi: 10.1371/journal.pone.0138294. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jih-Shuin Jerng, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jih-Shuin Jerng, MD, PhD (0972651075, jsjerng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of weaning parameters after tracheostomy (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.